Actively Recruiting
Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Led by Wei Jiang · Updated on 2023-05-03
440
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
W
Wei Jiang
Lead Sponsor
W
Wuzhou Red Cross Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved as the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.
CONDITIONS
Official Title
Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with non-keratinizing nasopharyngeal carcinoma confirmed by tissue analysis
- Tumor stage III to IVb according to the 8th edition AJCC
- Female participants who are not pregnant
- Age between 18 and 65 years
- Normal blood counts (hemoglobin >10 g/dL, white blood cells ≥4000/µL, platelets ≥100,000/µL)
- Normal liver function (bilirubin ≤1.6 mg/dL, liver enzymes less than 2.5 times upper limit)
- Normal kidney function (creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min)
- ECOG performance status 0 or 1
- No prior chemotherapy or radiotherapy
- Signed informed consent provided
You will not qualify if you...
- Disease progressing during treatment
- Uncontrolled life-threatening illness
- Previous chemotherapy or radiotherapy
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
Actively Recruiting
2
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543002
Actively Recruiting
Research Team
W
Wei Jiang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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